Level B· Emerging clinical evidence with positive signalsRandomized Controlled TrialEurope PMCOpen access

Evidence-based guidelines on orthobiologics

Winkler T., Oehme S., Hildebrandt A., Paolucci A., Pichler L.

Randomized Controlled Trial on Knee Osteoarthritis, Osteoarthritis, Ankle Injury, published in EFORT Open Rev (2025) — summary generated from the PubMed abstract.

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Level B· Emerging clinical evidence with positive signalsEvidence level of this study

Several human studies show positive signals, while research methods and sample sizes continue to develop.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
Read the A–D evidence level guide

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Randomized Controlled Trial
Journal
EFORT Open Rev (2025)
Reported sample size
—
Source database
Europe PMC
PMID
40459170
PMCID
PMC12139597
DOI
10.1530/eor-2025-0069

Abstract (original English)

Orthobiologics (OBs) have seen a constant increase in the number of available therapies and their clinical applications. Existing therapies can be categorized into blood-based (e.g., platelet-rich plasma (PRP)) and tissue/cell-based (e.g. mesenchymal stromal cells) approaches. While the popularity of OBs continues to grow, their diverse natures create unique challenges for the establishment of evidence-based guidelines. PRP has been reported by meta-analyses to increase patient-reported outcomes for conditions such as knee osteoarthritis (KOA), lateral epicondylitis and plantar fasciitis. However, the randomized controlled trials (RCTs) included often exhibit a high risk of bias due to the heterogeneity in the PRP preparation protocols and accompanying measures as well as inconsistent trial quality. The development pipeline of cell/tissue-based therapies is typically longer and more cost-intensive than that of blood-based therapies. Nevertheless, several products have demonstrated clinical safety. While some RCTs and meta-analyses on the outcome of cell/tissue-based therapies exist, their number is considerably lower than that of blood-based therapies and they focus mainly on KOA, with limited evidence on other orthopedic indications. Orthopedic societies such as ESSKA and AAOS have taken on the challenge of developing guidelines for OBs by combining high-level synthesized evid

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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